OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: IVUS; Device: OFDI

Study type: Interventional

Funder types: Other

Identifiers

NCT01873027

UMIN000010580 (Registry Identifier)

TRICVD1225

Details and patient eligibility

About

The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.

Full description

Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.

The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.

We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.

Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.

Enrollment: 829 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
• Patients aged between 20 and 85 years old
• Patients who has provided written informed consent

Exclusion criteria

• Patients with Acute Myocardial Infarction (AMI) within 3 months

• Patients with cardiogenic shock

• Patients with chronic heart failure

• Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)

• Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.

• Patients planned use of bare metal stent

• Patients with 3-vessel diseases

• Planned surgery within 1 year

• Patient on dialysis

• Target lesion such as:

  • Left main coronary artery
  • Aorto-Ostial lesion location within 3mm of the aorta junction
  • Chronic total occlusion
  • Small vessel (reference vessel diameter <2.5mm)
  • Coronary artery bypass graft

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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829 participants in 2 patient groups

OFDI-guided PCI

Experimental group

Description:

* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.

Treatment:

Device: OFDI

IVUS-guided PCI

Active Comparator group

Description:

* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI * Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.

Treatment:

Device: IVUS